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budesonide (Cortiment)

Advice

following a resubmission:

budesonide (Cortiment®) is accepted for restricted use within NHS Scotland.

Indication under review: in adults for induction of remission in patients with mild to moderate active ulcerative colitis (UC) where aminosalicylate (5-ASA) treatment is not sufficient.

SMC restriction: for use in patients with UC who present with active left-sided disease and/or proctosigmoiditis who are not suitable for oral prednisolone, as an alternative to budesonide rectal formulations or off-label oral budesonide. 

In two phase III studies, budesonide (Cortiment®) significantly increased combined clinical and endoscopic remission at eight weeks compared with placebo. However, there are no comparative data with other oral or rectal preparations. 

Drug Details

Drug Name: budesonide (Cortiment)
SMC Drug ID: 1093/15
Manufacturer: Ferring Pharmaceuticals Ltd
Indication: in adults for induction of remission in patients with mild to moderate active ulcerative colitis (UC) where aminosalicylate (5-ASA) treatment is not sufficient.
BNF Category:
Sub Category: 1.5 Chronic bowel disorders
Submission Type: Resubmission
Status: Restricted
Date Advice Published: 10 October 2016

Archived Advice

Abbreviated Submission 12 October 2015

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